MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-04-30 for CONVATEC LOOP OSTOMY ROD 22355 manufactured by Convatec.
[379474]
Convatec was notified by a clinician that a loop ostomy rod was used on a pt and was removed 7 days post-op. The nurse was able to unlock the mechanism easily but when the rod was removed the tip was missing. The pt's physician chose not to probe for the missing piece. The pt was not injured in any way during the removal of the rod. The pt was discharged. Convatec followed up with the nurse and dr to confirm pt had not suffered any injuries; this was confirmed. 6/1998 - convatec was notified that pt returned to the hosp for closure of the colostomy. During the closure surgery the missing piece of the loop ostomy rod was found. It was removed and the pt suffered no adverse effects.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1049092-2005-00012 |
| MDR Report Key | 599256 |
| Report Source | 05 |
| Date Received | 2005-04-30 |
| Date of Report | 2005-04-29 |
| Date of Event | 1998-03-09 |
| Date Mfgr Received | 1998-03-10 |
| Date Added to Maude | 2005-05-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR |
| Manufacturer City | SKILLMAN NJ 08858 |
| Manufacturer Country | US |
| Manufacturer Postal | 08858 |
| Manufacturer Phone | 9089042630 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CONVATEC LOOP OSTOMY ROD |
| Generic Name | OSTOMY ROD |
| Product Code | EZP |
| Date Received | 2005-04-30 |
| Model Number | NA |
| Catalog Number | 22355 |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 589082 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR SKILLMAN NJ 08558 US |
| Baseline Brand Name | CONVATEC LOOP OSTOMY ROD |
| Baseline Generic Name | OSTOMY ROD |
| Baseline Model No | NA |
| Baseline Catalog No | 22355 |
| Baseline ID | NA |
| Baseline Device Family | OSTOMY ROD |
| Baseline Shelf Life Contained | N |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K811240 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2005-04-30 |